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Senior Manager, GxP Training Program
Andover, MA
Job Description
The Sr. Manager, GxP Training position is responsible to manage Sarepta's global GxP Training Program. The position will reside on-site in the Andover, MA facility, reporting to the Director of Global Quality Systems.
The position encompasses a variety of training management responsibilities, including maintaining a compliant GxP Training Program in accordance with US and International guidelines and regulatory requirements; maintaining a validated electronic learning management system (Veeva Training Vault); owning training SOPs and materials within area of responsibility; designing and delivering training courses to personnel; collaborating with functional areas to identify and training roles/curricula assignments; and ultimately ensuring the training program is fit for use and functioning in a healthy/compliant state. This Sr. Manager, GxP Training will also serve as the primary point of contact for all corporate wide training needs specific to GCP/GCLP/GLP/GVP/GPP/GRP areas of practice.
This role will work closely with QA Compliance / Quality Systems personnel to ensure sustained compliance across Sarepta's global Quality Management System.
The position encompasses a variety of training management responsibilities, including maintaining a compliant GxP Training Program in accordance with US and International guidelines and regulatory requirements; maintaining a validated electronic learning management system (Veeva Training Vault); owning training SOPs and materials within area of responsibility; designing and delivering training courses to personnel; collaborating with functional areas to identify and training roles/curricula assignments; and ultimately ensuring the training program is fit for use and functioning in a healthy/compliant state. This Sr. Manager, GxP Training will also serve as the primary point of contact for all corporate wide training needs specific to GCP/GCLP/GLP/GVP/GPP/GRP areas of practice.
This role will work closely with QA Compliance / Quality Systems personnel to ensure sustained compliance across Sarepta's global Quality Management System.
Primary responsibilities will include the following:
- Ensure compliance with global regulations and Sarepta's Training Policy; maintain internal training SOPs and related content that's fit for use across all GxP areas.
- Develop and execute formal R&D and GxP (GCP/GCLP, GLP, GVP, GRP, and GPP) related training to personnel.
- Oversee records and training history information, along with employee qualification/competency records - maintain and retain appropriately.
- Maintain validated LMS (Veeva Training Vault) and support system enhancements and end user training, as assigned.
- Serve as the Training System SME during audits/regulatory inspections; assist in inspection preparation and ensure the Training Program is 'inspection ready' at all times.
- Work cross-functionally to help develop role-based training curricula; partner with training team and stakeholders & ensure minimum training requirements, are assigned.
- Oversee Global GxP Training Coordinator Program (with GTCOE training team) to ensure on-site training support is available across all Sarepta locations (as deemed appropriate).
- Monitor training performance and provide KPI matrices/reports to management.
- Support system changes, impact assessments, and testing, as needed.
- Provide cross functional / back up support to other team members to ensure ample coverage.
- Participate in team/company initiatives in support of achieving Sarepta's goals.
Education and Skills Requirements:
- Bachelor's Degree or higher in a scientific discipline preferred.
- Minimum 10 years' experience in a similar Training management role within the Life Sciences industry; Global experience preferred.
- Understanding GxP Quality Requirements, expertise in GCP/Clinical Development required.
- Experience administering an electronic LMS/Training Management System is a must.
- Advanced computer skills utilizing MS Office Products (i.e., MS Word and Excel) and Adobe Captivate to create SCORM files preferred.
- Change agent personality; identifies continuous improvement opportunities and drives innovation.
- Strong team player with demonstrated track record of success in a cross-functional team and fast moving environment.
- Excellent organizational, computing and oral/written communication skills.
- Ability to influence and negotiate effective solutions.
- Strong critical thinking and decision-making skills.
#LI-TG1
#LI-HybridThis position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $132,000 - $165,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
10+ years
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